Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00630487
• Date of registration: 28/02/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency IGHD
• Scientific title: Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)
• Date of first enrolment: May 2008
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00630487
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females between 18 and 65 years of age

- Isolated growth hormone deficiency

Exclusion Criteria:

- Isolated growth hormone deficiency by childhood onset

- Diabetes mellitus type 1 or 2



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: Placebo

Drug: Somatropin

Primary Outcome(s)

Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI) [Time Frame: Baseline, 52 weeks]

Secondary Outcome(s)

Change From Baseline in Blood Pressure [Time Frame: Baseline, Week 52, Week 78]

Change in Executive Function and Memory in Subgroups [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in Anthropometric Parameters (Height) [Time Frame: Baseline, 52 weeks, 78 weeks]

Change From Baseline in Safety Laboratory Assessments [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in Anthropometric Parameters (Waist Circumference) [Time Frame: Baseline, 52 weeks, 78 weeks]

Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in Cardiovascular Risk Factors [Time Frame: Baseline, Week 52, Week 78]

Change in Visceral Fat Mass in Subgroups [Time Frame: Baseline, 52 weeks, 78 weeks]

Change From Baseline in Homeostasis Model Assessment (HOMA)-Index [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in Short Form (36) Health Survey (SF36) [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in Heart Rate [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT]) [Time Frame: Baseline, Week 52, Week 78]

Change From Baseline in Anthropometric Parameters (Weight) [Time Frame: Baseline, 52 weeks, 78 weeks]

Secondary ID(s)

A6281282

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/01/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00630487